Clinical Trial: A Clinical Study of Fundus Findings in Toxaemia of Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)

Brief Summary:

Toxemia of pregnancy is a recognized entity for over 2000 years with its known complications and fatality. Nowadays, a most accepted terminology for the following defined syndrome is "hypertensive disorders in pregnancy" given by American College of Obstetrics and Gynecology. It is an important cause of maternal and fetal morbidity and mortality. Pregnancy induced hypertension (PIH) was classified as gestational hypertension, preeclampsia, severe preeclampsia and eclampsia. PIH is a hypertensive disorder in pregnancy that occurs after 20 weeks of pregnancy in the absence of other causes of elevated blood pressure (BP) (BP >140/90 mmHg measured two times with at least of 4 hour interval) in combination with generalized edema and/or proteinuria (>300 mg per 24 hrs). When there is significant proteinuria it is termed as preeclampsia; seizure or coma as a consequence of PIH is termed as eclampsia. Preeclampsia was classified into mild and severe preeclampsia.

Mild eclampsia—BP >140/90 mmHg, proteinuria+, and/or mild edema of legs, Severe preeclampsia—BP >160/110 mmHg,proteinuria++ or ++++, headache, cerebral or visual disturbances, epigastric pain, impaired liver function tests and increase in serum creatinine.

Proteinuria was tested using dipstick method as +=0.3 gm/L, ++=1 gm/L, and +++=3 gm/L.

The pathological changes of this disease appear to be related to vascular endothelial dysfunction and its consequences (generalized vasospasm and capillary leak). Ocular involvement is common in PIH.Common symptoms are blurring of vision, photopsia, scotomas and diplopia. Visual symptoms may be the precursor of seizures.Progression of retinal changes correlates with progression of PIH and also with the fetal mortality due to similar vascular ischemic c

Detailed Summary:

An observational study in which the patients for the study are selected from antenatal clinic, antenatal ward and "preeclampsia and eclampsia room" in Department of Obstetrics and Gynecology and general Ophthalmic Out Patient Department(OPD) in case of ambulatory patients during the period of November 2003 to June 2006 randomly.In every case, detail obstetric history including a detail antenatal history was taken. General examination and relevant pathological investigations like routine blood count, HIV, HBsAg, renal function tests, TORCH complex etc., were carried out. In every case, pupil was dilated with homatropine (2%) eye drops. Then detailed ophthalmic examination was carried out with special emphasis on direct ophthalmoscopy apart from visual acuity of both eyes and anterior segment examination. Fundus findings were noted in detail, changes in the color of the disc, disc margin, physiological cup, changes in retinal blood vessels especially caliber of vessels, arterio‑venous (AV) ratio,changes in vessel wall, blood column, appearance of vascular light reflex, changes at AV crossings, changes in macular area and changes in background, overall appearance, presence of hemorrhages, exudates or any pathology were recorded.

Fundus changes were graded as per modified Keith, Wagner and Barker classification.Assessment of prognosis as regards to vision and life (mortality) was made.

Sponsor: B. J. Medical College, Ahmedabad

Current Primary Outcome:

• The relation of positive fundus changes with number of cases of pregnancy induced hypertension [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with disease entity.In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.
• The relation of number of cases of PIH and positive fundus findings with number of gravida [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with gravida.
• Relationship between total number of cases of PIH and fundus changes according to age [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with age.
• Relationship between number of cases of PIH and fundus changes according to duration of pregnancy [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with duration of pregnancy
• The relation of number of cases of PIH and fundus findings with systolic blood pressure [ Time Frame: Nov. 2003 to June 2006 randomly ]

  In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.

• The relation of positive fundus changes with number of cases of pregnancy induced hypertension [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with disease entity.In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.
• The relation of number of cases of PIH and positive fundus findings with number of gravida [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with gravida.
• Relationship between total number of cases of PIH and fundus changes according to age [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with age.
• Relationship between number of cases of PIH and fundus changes according to duration of pregnancy [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Correlation of fundus changes with duration of pregnancy
• The relation of number of cases of PIH and fundus findings with systolic blood pressure [ Time Frame: Nov. 2003 to June 2006 randomly ]

  In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.

• Distribution of PIH cases on fetal outcome [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome.
• The relation of fundus changes with perinatal mortality [ Time Frame: Nov. 2003 to June 2006 randomly ]
  Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome and perinatal mortality.

Original Secondary Outcome: Same as current

Information By: B. J. Medical College, Ahmedabad

Dates:
Date Received: October 30, 2016
Date Started: November 2003
Date Completion:
Last Updated: March 10, 2017
Last Verified: March 2017